Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VV-ECMO.
- Who it may be relevant to
- Registry conditions: Extracorporeal Membrane Oxygenation Complication, Cerebral Circulatory Failure. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a supportive therapy, indicated in case of severe, possibly reversible pulmonary failure, refractory to conventional therapies. Despite advances, morbidity and mortality remain high. Severe neurological complications can occur during ECMO, but their exact etiology is not well understood. It is hypothesized that fast correction of severe hypercapnia, a common indication for venovenous ECMO, may be detrimental for the brain. The supposed mechanism is that fast correction of hypercapnia may result in massive cerebral vasoconstriction and impaired cerebral blood flow (CBF). In this prospective, observational study the aim is to quantify change in CBF during routine initial correction of severe hypercapnia during VV-ECMO. Furthermore, the investigators will record any other hemodynamic changes during VV-ECMO. The hypothesis is that a larger decline in PaCO2 will result in a larger decline of CBF.
Interventions
- Device VV-ECMO
VV-ECMO is indicated in case of severe respiratory failure refractory to other therapies. Indications for VV-ECMO include severe pneumonia, acute respiratory distress syndrome (ARDS) (a.o. due to COVID-19) or near-drowning. ECMO is considered a 'last resort' therapy, in which other maneuvers - such as prone positioning and neuromuscular blockage - have shown to be insufficient. Patients are generally receiving invasive mechanical ventilation and are almost always unconscious, since due to the se
Primary outcome measures
- Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec) [Time frame: Before,during and after start of VV-ECMO,consisting of:starting 1 hour in advance of ECMO initiation, continuing until a maximum of 1 hour after the last change in SGF. 24 hours after ECMO initiation another measurement of 30 minutes will be performed.]
Eligibility criteria
Inclusion Criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria:
- High suspicion of an indication for VV-ECMO;
- Arterial line present to enable blood sampling;
- Older than 18 years.
Exclusion criteria
- Subjects will be excluded if the cerebral blood flow cannot be measured using the transcranial Doppler
- VA-ECMO or ECPR;
- No possibility for neuromonitoring measurements due to technical difficulties, e.g. post-craniotomy, unsuitable transcranial window;
- No possibility for neuromonitoring measurements due to circumstantial difficulties, e.g. ECPR;
- Contraindications for ECMO;
- ECMO is initiated in another center.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam-Zuidoost
Identifiers
NCT: NCT05303363 · W21_486 # 21.539